Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

The purpose of this retrospective registry is to collect data about patients with acute HIT II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid, Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily routine in this indication in Germany.

Study Overview

• Status: Completed
• Conditions: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
• Intervention / Treatment: Drug: fondaparinux; Drug: lepirudin; Drug: danaparoid; Drug: argatroban

• Study Type: Observational
• Enrollment (Actual): 195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients with HIT

Description

Inclusion Criteria:

• Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
• Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lepirudin; lepirudin treated subjects	Drug: lepirudin; lepirudin
danaparoid; danaparoid treated subjects	Drug: danaparoid; danaparoid
argatroban; argatroban treated subjects	Drug: argatroban; argatroban
fondaparinux; fondaparinux treated subjects	Drug: fondaparinux; fondaparinux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II	Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).	19 January 2005 to 25 October 2009

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.	19 January 2005 to 25 October 2009
Number of Participants With Fatal Complications After the Occurrence of HIT II	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.	19 January 2005 to 25 October 2009
Number of Participants Who Underwent Amputation After the Occurrence of HIT II	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).	19 January 2005 to 25 October 2009
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.	19 January 2005 to 25 October 2009
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.	19 January 2005 to 25 October 2009

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Schindewolf M, Steindl J, Beyer-Westendorf J, Schellong S, Dohmen PM, Brachmann J, Madlener K, Potzsch B, Klamroth R, Hankowitz J, Banik N, Eberle S, Muller MM, Kropff S, Lindhoff-Last E. Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia. J Am Coll Cardiol. 2017 Nov 28;70(21):2636-2648. doi: 10.1016/j.jacc.2017.09.1099.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Fondaparinux; PENTA; Argatroban; Danaparoid; Lepirudin
• Other Study ID Numbers: 108745